Moxifloxacin vs. Polytrim for Conjunctivitis

Phase 4

Completed

• Conditions: Conjunctivitis
• Interventions: Drug: polytrim; Drug: moxifloxacin

• Registration Number: NCT00581542
• Lead Sponsor: University of Rochester

Brief Summary

The purpose of the study is to compare the effect of Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution in treating your child's pink eye. Both these medications are approved by the Food and Drug Administration, for treatment of conjunctivitis. This study will investigate if both of the medications are equally good.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Primary Completion: 2009-03
• Study Completion: 2012-03
• Results First Submitted: 2015-04-15
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-11
• Last Update Submitted: 2015-12-11
• Results First Posted: 2016-01-18
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• 1 - 18 years of age with presumed bacterial conjunctivitis.

Exclusion Criteria

• Previous antibiotics or to receive systemic antibiotic.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxifloxacin Opthalmic solution	polytrim	-
Polymyxin B-trimethoprim opthalmic solution	moxifloxacin	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Normal Physical Examination of the Eye	10 days

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Negative Bacterial Culture	10 days	Conjunctival swab specimens were inoculated onto tryptic soy agar with 5% sheep blood and GC II agar supplemented with hemoglobin and isovialex with incubation at 35 degrees C in ambient air supplemented with 5% carbon dioxide for 48 hours. S pneumoniae, H influenzai and M Catarrhalis were identified.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States